FDA asks Coast to stop reviewing new studies
The Food and Drug Administration has asked Colorado Springs-based Coast Independent Review Board to stop reviewing new FDA-regulated studies and to direct investigators in ongoing studies to stop enrolling new patients.
Coast IRB is a for-profit institutional review board, whose role is to ensure the safety of patients in medical tests. The company oversees 300 human research trials, according to the FDA.
A Coast spokeswoman said the company had no comment today and that Coast CEO Dan Dueber would not speak with the press.
Last year, Coast IRB was caught in a sting operation conducted by the Government Accountability Office in which GAO investigators set up a fake study of a fake medical procedure and submitted it to three IRB companies for review. Coast was the only one of the three to approve the trial. A Congressional subcommittee investigating the sting last month had harsh words for Dueber.
"The evidence suggests that Coast was more concerned with its bottom line than it was with patient safety," said subcommittee Chairman Rep. Bart Stupak, D-Mich., during the hearing.
Dueber was defiant at the time, calling the government's investigation "completely unconscionable." However, he also invited the FDA to do a top-down review of the company and, on March 30, Coast announced that it was conducting an internal audit of its procedures and voluntarily suspended reviewing new study submissions until May 1.
The FDA said it will actively monitor the company and that the restrictions will remain in place until it is satisfied Coast is adequately complying with regulations that protect the safety of human research subjects and that Coast has 15 working days to submit a plan to bring the company into compliance. The FDA said Coast voluntarily complied with the restrictions.
